The Dholka manufacturing plant of Cadila Pharmaceuticals has successfully cleared the US Food and Drug Administration (USFDA) audit yet again.
The Dholka manufacturing facility, Situated in the state of Gujarat passed the USFDA audit with Zero 483 observations, which signifies compliance and conformance to applicable Current Good Manufacturing Practice (cGMP) regulations enforced by the USFDA. USFDA Inspector Vivin George conducted the facility’s audit from April 3 to 7.
Clearing the USFDA audit with nil 483 observations means Cadila Pharmaceuticals can continue to export its high-quality medicines made at the Dholka manufacturing facility to the US, the world’s largest and most stringent drug market.
The Chairman and Managing Director Dr Rajiv I Modi, congratulated the team at the Dholka facility, stating that their commitment to quality control in the design and manufacturing process was evident in the audit’s outcome.
Dr Rajiv I. Modi, Chairman & Managing Director of Cadila Pharmaceuticals said, “We are pleased that our Dholka manufacturing facility has cleared the USFDA inspection with nil 483 observations. In all our facilities, quality control is inbuilt at every step in the design and manufacturing process. The successful completion of the USFDA audit is a strong validation of our commitment to ensure the availability of medicines that meet the most stringent global quality standards. I also take this opportunity to congratulate our team at the Dholka facility.”